NCT01413139已完成4 期
4-EVER Study - Physician-Initiated Trial Investigating the Safety of the Full 4F Endovascular Treatment Approach of Infra-Inguinal Arterial Stenotic Disease
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 10
- 主要终点
- Primary patency at 12 months as indicated by an independently verified duplex ultrasound peak systolic velocity ratio (PSVR) <2.5 in the target vessel with no reintervention
研究概览
简要总结
The objective of this clinical investigation is to evaluate puncture site complication rate as well as the short- and long-term (up to 24 months) outcome of treatment by means of Astron Pulsar / Astron Pulsar-18 stent implantation in symptomatic (Rutherford 2-4) femoro-popliteal arterial stenotic or occlusive lesions, using 4F compatible devices of BIOTRONIK and without the use of a closure device.
The hypothesis is that the primary patency at 12 months is non-inferior to the primary patency obtained in the Durability study (72.2%).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •De novo, restenotic or reoccluded lesion located in the femoropopliteal arteries suitable for endovascular treatment
- •Patient presenting with a score from 2 to 4 according to the Rutherford classification
- •Patient is willing to comply with specified follow-up evaluations at the predefined time intervals times
- •Patient is >18 years old
- •Patient understands the nature of the procedure and provides written informed consent, prior to enrollment in the study
- •Prior to enrollment, the target lesion was crossed with standard guidewire manipulation
- •Patient is eligible for treatment with 4F compatible devices
- •Angiographic Inclusion Criteria:
- •The target lesions are located within the native superficial femoral artery: Distal point 3 cm above knee joint and 1 cm below the origin of the profunda femoralis.
- •The target lesion has angiographic evidence of stenosis or restenosis > 50% or occlusion
- •Length of the target lesion is =20 cm by visual estimation and can be covered with one stent
- •Target vessel diameter visually estimated is =4 mm and =6.5 mm
- •There is angiographic evidence of at least one-vessel-runoff to the foot
排除标准
- •Presence of another stent in the target vessel that was placed during a previous procedure
- •Presence of an aortic thrombosis or significant common femoral ipsilateral stenosis
- •Previous bypass surgery in the same limb
- •Patients contraindicated for antiplatelet therapy, anticoagulants or thrombolytics
- •Patients who exhibit persistent acute intraluminal thrombus at the target lesion site
- •Perforation at the angioplasty site evidenced by extravasation of contrast medium
- •Patients with known hypersensitivity to nickel-titanium
- •Patients with uncorrected bleeding disorders
- •Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding
- •Life expectancy of less than 12 months
- •Ipsilateral iliac artery treatment before target lesion treatment with a residual stenosis > 30%
- •Use of thrombectomy, atherectomy or laser devices during procedure
- •Any planned surgical intervention/procedure 30 days after the study procedure
- •Any patient considered to be hemodynamically unstable at onset of procedure
- •Patient is currently participating in another investigational drug or device study that has not reached the primary endpoint
结局指标
主要结局
Primary patency at 12 months as indicated by an independently verified duplex ultrasound peak systolic velocity ratio (PSVR) <2.5 in the target vessel with no reintervention
时间窗: 12 months
Primary patency at 12 months, defined as freedom from \>50% restenosis
次要结局
- Primary patency(6- & 24-month follow-up)
- Clinical success(6-, 12- & 24-month follow-up)
- Stent fracture rate at 12- & 24-month follow-up(12- & 24-month follow-up)
- Technical success(1 day post-procedure)
- Puncture site complications(10 days)
研究者
研究点 (10)
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